Alembic Pharmaceuticals has received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for its generic of cancer drug Bosutinib Tablets, 400 mg.
Bosutinib Tablets, 400 mg, had an estimated market size of $251 million for the twelve months ended September 2025, the drugmaker said, citing IQVIA numbers, in a release announcing the tentative approval for its supplemental abbreviated new drug application (sANDA). Alembic had previously received final approval for its ANDA for Bosutinib Tablets, 100 mg and 500mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product Bosulif Tablets 400 mg of PF Prism C.V. A kinase inhibitor, Bosutinib is indicated for the treatment of adults with chronic phase Ph+ chronic myelogenous leukaemia (CML), newly-diagnosed or resistant or intolerant to prior therapy and adults with accelerated or blast phase Ph+ CML with resistance or intolerance to prior therapy.
Published – January 12, 2026 08:05 pm IST
